GXQ — Dura Substitute Class II
FDA product code GXQ covers "Dura Substitute", a Class II medical device regulated under 21 CFR 882.5910. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GXQ
- Device Class
- Class II
- Regulation Number
- 882.5910
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251191 | collagen matrix | Collagen Dura Regeneration Membrane - Repair | November 18, 2025 |
| K250420 | helios biomedical | Helios Dura Regeneration Matrix | May 14, 2025 |
| K223445 | nurami medical | ArtiFascia | August 10, 2023 |
| K212943 | synthes (usa) products | SyntheCel Dura Repair | January 28, 2022 |
| K183513 | lemaitre vascular | XenoSure Dura Biologic Patch | June 13, 2019 |
| K172603 | acera surgical | Cerafix Dura Substitute | November 27, 2017 |
| K163456 | integra lifesciences corporation | DuraGen Secure Dural Regeneration Matrix | January 6, 2017 |
| K161370 | medtronic neurosurgery | Durepair Dura Regeneration Matrix | November 2, 2016 |
| K161278 | acera surgical | Cerafix Dura Substitute | August 8, 2016 |
| K153613 | acera surgical | Cerafix Dura Substitute | March 16, 2016 |
| K150825 | collagen matrix | Collagen Dural Regeneration Matrix | November 20, 2015 |
| K152481 | codman and shurtleff | DURAFORM Dural Graft Implant | October 30, 2015 |
| K141608 | collagen matrix | COLLAGEN DURA MEMBRANE | January 16, 2015 |
| K132850 | rti surgical | BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE P | March 31, 2014 |
| K131792 | synthes | SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY | December 16, 2013 |
| K131015 | cook biotech | BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT | October 8, 2013 |
| K122791 | aesculap | LYOPLANT ONLAY | June 4, 2013 |
| K120600 | integra life sciences | DURAGEN SECURE DURAL REGNERATION MATRIX | June 15, 2012 |
| K113071 | synthes | SYNTHECEL DURA REPLACEMENT DEVICES | January 9, 2012 |
| K092388 | integra lifesciences corporation | DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA S | January 21, 2010 |